Mylan Pharmaceuticals launches Rabeprazole Sodium Delayed-release Tablets

Nov 11 2013

Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Rabeprazole Sodium Delayed-release Tablets, 20 mg. Rabeprazole Sodium Delayed-release Tablets are the generic version of Eisai Corporation's Aciphex^® Tablets, and are indicated for short-term treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease, and for short-term treatment in the healing and symptomatic relief of duodenal ulcers. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.

Aciphex Tablets, 20 mg, had U.S. sales of approximately $830.1 million for the 12 months ending Sept. 30, 2013, according to IMS Health.

Currently, Mylan has 179 ANDAs pending FDA approval representing $90.5 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health.